A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
- Registration Number
- NCT05362045
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
Inclusion Criteria
- Body mass index between 18 and 32 kg/m^2, inclusive, at the Screening Visit
- Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1
Exclusion Criteria
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mavacamten- Dose B Mavacamten - Mavacamten- Dose A Mavacamten -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to approximately 1 month Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T)) Up to approximately 1 month Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) Up to approximately 1 month
- Secondary Outcome Measures
Name Time Method Time of maximum observed plasma concentration (Tmax) Up to approximately 1 month Terminal half-life (T-HALF) Up to approximately 1 month Number of participants with adverse events (AEs) Up to approximately 1 month Number of participants with serious adverse events (SAEs) Up to approximately 1 month Number of participants with vital sign abnormalities exceeding predefined thresholds Up to approximately 1 month Number of participants with electrocardiogram (ECG) abnormalities Up to approximately 1 month Number of participants with physical exam abnormalities Up to approximately 1 month Number of participants with clinical laboratory evaluation abnormalities Up to approximately 1 month
Trial Locations
- Locations (4)
Clinical pharmacology of Miami
🇺🇸Miami, Florida, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
Ppd Phase I Clinic
🇺🇸Austin, Texas, United States
QPS Springfield
🇺🇸Springfield, Missouri, United States